HARPC

For those of us in Canada - The HARPC program is a new twist that needs to be adressed.  HARPC is an American FDA program and is the acronym for Hazard Analysis and Risk-based Preventive Controls.  It is part of the FDA food modernization act and is meant for all US based non-regulated food companies.  Any US based company that is "regulated" with a HACCP plan is exempt from the HARPC program. 

All food companies, exporting food to the USA, need to have a HARPC plan registered with the US FDA.  Below are only a few websites that have good info on this program.  It seams to me that if you are certified with a GFSI program, you should be good for HARPC.  You will still need to send your HARPC plan to the FDA.

I do like the idea of HARPC being "risk" based.  Also, HARPC does look at all hazards - not just bio terrorism.  One fault, in my opinion is, this program does not seam to mention food FRAUD.  If fraud were to be addressed in HARPC - it would take the US program to a new, higher level.


http://www.harpc.com/what-is-harpc/
http://www.foodsafetytech.com/FoodSafetyTech/Features1/Moving-from-HACCP-to-HARPC-1591.aspx
http://www.foodprocessing.com/articles/2013/fda-haccp-harpc/
https://www.aibonline.org/newsletter/Magazine/.../8AreYouQualified.pdf
http://www.fdaimports.com/industries/food_beverages/food_safety_mod_act_2011/harpc_risk_prevention.php
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Food Quality Assurance and Food Safety

During my career I have had several job interviews that ask for a Quality Manager who has experience in HACCP and Food Safety.  This is puzzling since HACCP IS a food safety program and IS administered by the QA Department.  So - what is in the mind set of companies that separate the two functions?  Below are definitions for the two areas;

Food Quality Assurance:

The acceptable characteristics, of the product being sold, where the acceptability is determined by the customer/consumer.  This can include size, shape, texture, package size, flavor, colour, nutritionals, or even functionality.  Sanitary working conditions are a factor which deal with elimination of chemical, physical, microbiological contamination.  Other regulatory topics are also included – Hallal, Kosher, Allergen, traceability, organic.  This all is combined in the activities of the “Quality System” which include the day to day testing performed as quality control.

Food Safety: 

Safety specifically deals with the handling/preparation/storage/transportation of food to prevent foodborne illness.

It does sound as if Food Safety is HACCP.  However, HACCP does include physical and chemical contamination as well as the microbiological issues that can cause foodborne illness.  Unfortunately, at this time, a company can divide and name jobs/functions as they wish.  This does cause ambiguity and misconceptions. 

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 To me the notions of QA and Safety can be summed up as Quality Assurance (Quality Systems) is the overall policy program which has both quality control and food safety running below it.  The QA Manager should have a food safety supervisor and a quality control supervisor under them.

Validation Audit

OK – I generally talk about the various issues and techniques around the Food Safety and Food Quality programs.  What I have not written about is best practices.  I recently saw a particular best practice and wished to share.  If you (as a reader) have a best practice – please tell me about it.  The one that I saw related to Validation audits.

We know that we need to do validcation audits as part of HACCP and GFSI systems.  But how do we structure / organize the audit?  Here are my thoughts and the best practice that I recently saw.

 STEP 1: Training

A .Train personnel on how to conduct themselves as auditors and how to conduct an audit.
B. Know that Validation audits should be done by personnel who are not responsible for the area being audited.
C. Create a matrix of who audits and which element of the the GFSI system.

 STEP 2: The Schedule

Create a folder in Outlook or a calendar specific for when each audit is to occur / who will do the audit / and when all CARs (Corrective Action Required) and other various due dates are required for completion. 
 

STEP 3: The Folder                                                          

Create a folder for each process being audited. From what I have seen, this folder has several areas and everything for the audit is in one folder.

Section A – Front of folder.  All SOPs and Policies, pertaining to the element, are attached.  Auditor is to review the SOPs / Policies before conducting the audit.  To understand the element training may need to be conducted so the auditor understands the element that they will be verifying.

Section B – The Audit Form. 

 

 

 Section C – Back of folder information.  Attach blank copies of all records / logs that pertain to the validation audit.  This is for reference only.

 STEP 4: After Audit.

Return the audit to the responsible manager and audit committee for review, creation of CARs, action plans and due dates.  There should also be regularly scheduled meetings to review audits and keep all members up-to-date.

 

 

 

Canadian Food Regulation Links

As promised in my last blog of September 11, 2013, enclosed are some links to food regulation related Canadian Federal sites.

1.       Canadian Agricultural Products Act: http://laws-lois.justice.gc.ca/eng/acts/C-0.4/

2.       Canadian Food and Drug act and Regulations: http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/act-loi_reg-eng.php

3.       cGMP: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/index-eng.php

4.       Compendium of Templates for “Nutrition Facts” Tables: http://www.colorado.gov/cs/Satellite?blobcol=urldata&blobheadername1=Content-Disposition&blobheadername2=Content-Type&blobheadervalue1=inline%3B+filename%3D%22Canadian+Nutrition+Facts+Labels.pdf%22&blobheadervalue2=application%2Fpdf&blobkey=id&blobtable=MungoBlobs&blobwhere=1251822422858&ssbinary=true

5.       Consumer Packaging and Labeling Act: http://laws-lois.justice.gc.ca/eng/acts/C-38/

6.       Fish Inspection Act: http://laws-lois.justice.gc.ca/eng/acts/F-12/

7.       Food Safety Enhancement Program Manual: http://www.inspection.gc.ca/DAM/DAM-food-aliments/STAGING/text-texte/food_fsep_man_1343667674768_eng.pdf

8.       Guide to food Safety: http://www.inspection.gc.ca/food/non-federally-registered/safe-food-production/guide/eng/1352824546303/1352824822033

9.       Guidelines on Methods for the Microbiological Analysis of Food.: http://www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/microbio/volume1/index-eng.php

10.   Laboratory Biosafety Guidelines: http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/

11.   Meat Inspection Act:  http://laws-lois.justice.gc.ca/eng/acts/M-3.2/

12.   Microbiological Safety of Foods: http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/index-eng.php#micro

13.   Nutrition labeling toolkit: http://www.inspection.gc.ca/english/fssa/labeti/nutrikit/nutrikite.shtml

14.   Safe foods for Canadians Act: http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/regulatory-initiatives/sfca/eng/1338796071420/1338796152395

15.   Safe Foods Production: http://www.inspection.gc.ca/food/non-federally-registered/safe-food-production/eng/1326392798878/1326392878891

16.   Seeds Act: http://www.inspection.gc.ca/plants/seeds/eng/1299173228771/1299173306579

17.   Weight and Measures Act: http://laws-lois.justice.gc.ca/eng/acts/w-6/

SAFE FOODS FOR CANADIANS ACT.

 

Seeing that there is this new legislation I thought that I would take a look and learn how this will change the food industry in Canada.  The legislation is new as of Nov 2012 and combines the Fish Act, Agricultural Act, Meat Inspection Act, and the Labelling Act.  The Food and Drug act remains separate as an umbrella policy.  to view the act go to http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/regulatory-initiatives/sfca/eng/1338796071420/1338796152395

 

As legislation – I found that this does not have much “meat” to it.  Effectively it outlines how the government will harmonize what the inspectors and CFIA do.  So – better and streamlined oversite of the food industry (one set of rules for all). 

 

Benefits:

1.       All sectors now require trace and recall programs
2.       More accountability on importers for food safety
3.       A new food export certification process
4.       Lists tampering with food as intent to harm and food fraud comes into focus with misleading labels and selling product with misleading labels or falsified documentation.

 

In the Appendix this document provides is a listing of all the relevant documents.  This will help Quality Professionals and companies to see if there are documents that they are not aware of.

 

In my next blog – I will do my own list of Canadian Federal  Government Acts and Regulation which are relevant to the food manufacturing industry.

Risk Management

I have mentioned "risk management" in previous blogs especially with regards to "Food Fraud".  But how do you conduct risk management and do a risk management analysis?  To start, when you find a process / procedure that has a risk associated with it there are three option.

1. Avoid dealing with the risk (poor business decision).
2. Deal with the risk via an action plan.
3. Knowingly (with reason) accept the risk and all potential  consequences.

Risk can come in various forms - Biological, physical, chemical, allergen, fraud, waste, etc.  Check our Wikipedia for a good primer on risk management   https://en.wikipedia.org/wiki/Risk_management.

Risk Management is common in the GFSI systems and HACCP programs.  The usage of risk management needs to be supported by upper management and practiced on a regular basis

HOW TO DO!

1. Perform a risk assessment.
• Based on Judgement and experience
• Identify and involve the "stakeholders" of the issue
• Uses science and knowledge
• Government laws need to be kept in mind such as "Canadian Food and Drug Act"
• Other standards used can include, BRC, SQF, Organic, Hallall, Fairtrade, ISO, Codex Alimentarius.
• Employ a risk Analysis Matrix
• Dark red area - Immediate action required.
• Red area - Critical area to have action plans and increase monitoring.
• Yellow area - regular monitoring schedules and management must be aware that the risk is present.
• Green area - May wish some monitoring if appropriate for the product.
• Matrix is used on one item / issue at a time.
• Codex (CAC/RCP1-1969, CAC/GL62-2007) has information on describing risk management but I find the above Matrix cleaner and easier to use.
2. Create Value
• Monitoring and corrective actions will cause resource and capital expenditure.  You will need to make a business case for the risk.  Some of these will be easy to do (Dark red and Red areas where Death or serious injuries may occur), other risks may need finance / accounting department to quantify the costs of the correction vs. the cost of the risk.
• The company may decide that the risk is low enough that it's acceptable to continue without correction.  Example - Overrun jelly donuts may get stale and produce customer complaints.  A solution is to scrap all overrun product.  If the cost to scrap the overrun is higher than the cost of complaints and brand image loss.
• The "Stakeholders" must buy into the analysis.
3. Must be Measurable
• Analysis is to be performed with a mind on the historical data, such as complaints, fines, loss of clients.
• Current data will need to be gathered to assess the effectiveness of the corrections.  If the correction is not effective the plan needs to be altered.  At this point a root cause analysis can be performed. A good way to see what is working, what is not working, and what needs to be done.
• Verification and Validation steps need to be put in place.  See my blog fro April 2013.
4. Transparent
• Report to management on the results and try to show how much $$$ was saved.
• Good to show staff the results in terms of lower complaint numbers, higher yields, or up time. 
• It is also beneficial to note the social / environmental impact of the change.  Customers are safer and lower waste and environment impact.

Root Cause Analysis - Revisited

Back in March I gave my thoughts on root cause analysis.  I discussed two methods that when used together are quite powerful.  These methods being Fishbone (brainstorming) and the 5 WHYS.  I have used these two methods to delve into issues that seem to be very persistent.  In other words - if a problem is persistent, the root cause has not been found.

There are a few more methods that can help in a roots cause determination.  Note: experience and judgement play a role in deciding which method(s) to use.  These other methods are;

1. The Interview.  I have used this and it can work to help find the issue.  WARNING - this can lead, very quickly, to the person being interviewed taking a very defensive attitude:  "Was not me, I don't know, why are you asking me these questions".  I think that a safe and open work culture needs to exist to make this method truly effective.
2. Flow chart.  Similar to the Fishbone but, in this case, the process steps are charted.  You must include all documented and undocumented steps.  Looking at all the steps can lead to finding the one piece that is causing the issue by being done or not done.
3. Alternate 5.  Asking Who - What - Where - When - Why - and sometimes the 6th How.
4. Pareto chart.  I discussed Pareto charts in a couple of other blogs - most recently on the blog of June 21, 2013.  This method states that 20% of causes result in 80% of your issues.  This is a great way to know what to spend your time on. 

The most current ideas behind root cause analysis tell us that the Quality Assurance department is no longer responsible for performing root cause analysis.  The best practice is to have the department with the issue be responsible for the root cause analysis.  Makes sense to me!  For example, if the issue is the amount of jelly being placed into donuts bring too variable - should it not be the people in charge of the jelly filling operation being the ones doing the root cause analysis?  After all, these operation people would have the most knowledge about the process, and have the most to gain from the root cause analysis exercise.  I think it could also help with employee engagement and empowerment.

NOTES OF CAUTION:

• Evaluation of the root cause effectiveness must be completed to evaluate if the problem has been solved.  This evaluation; if at all possible, should be accomplished through the collection and analysis of data. 
• Avoid using the words bad, poor, failed, careless, etc. when discussing the problem to be solved and it's possible causes.   Keep the analysis impersonal since you are fixing the system, not the people.

About Codex Alimentarius

I've been wanting to write this particular blog for awhile now.  In my professional career the Codex Alimentarius has been mentioned by the SQF / BRC standards, by teachers of HACCP, as well as GFSI consultants.  What has not occurred is,  anyone showing me the code.  I needed to look for it myself - which anyone can (the standards and documents are free).

A bit of History

Codex Alimentarius is Latin for "Food Code".  As my teachers, standards, etc said - the codex is a set of guidance documents based on Science.  The codex is (in the English version) a set of 324 documents.  This body of work has been compiled by an organization that was formed by the WHO (World Health Organization) and the FAO (Food and Agricultural Organization of the United Nations).   GFSI sources this code for their standards which, in turn, SQF / BRC / FSSC 2200 draw their standards.  Knowing the Codex, I have found, helps in the understanding of the various food accreditation schemes.


What is in the Codex?

 There are five types of documents in the codex:

1. Standards - Specific to various foods
2. Guidelines - items such as Nutritional Labeling
3. Miscellaneous - example, glossary of terms
4. MRL (one document) - Maximum Residual Limits for substances like pesticides
5. Codes of Practice - such as Principles for Food Hygiene

Of course, federal and regional governments may have laws that differ/exceed the Codex and must be adhered to.  It is also interesting to note, the Codex does reference ISO documents.  ISO is a great resource in understanding what is required of food production and safety.  ISO can also show where the codex will be in regard to new and updated standards.  For example, I am of the belief that "Food Security" and "Food Anti-Fraud" standards / guidelines will be more developed in the next few years because ISO is currently developing standards in these areas. 

Some Specific Documents to get You Started!

1. CAC/GL79-2012 - Control of Viruses in Food.  Interesting that this particular document looks at Design of Facilities in Section 4.  Specifically, that toilet facilities can be located next to processing areas but not with "direct access to" the processing area.  I did always wonder where this stipulation came from.  Canadian guidelines state that this is needed only for meat processing facilities or facilities supplying the meat processor.  I like what the Codex has stated - the toilets in all food processing facilities can not be accessed directly from the food processing areas.
2. CAC/GL50-2004 - Guidelines on Sampling.  Procedures on statistically relevant plans for the commodity being sampled.  Both for Quantitative and Qualitative data (see my blog of June 21, 2013).  This document also references ISO information and gets heavily into statistics.
3. CAC/GL60-2006 - Traceability Guidelines.  I found this very basic and looks to be something for governments to use and expand upon.
4. CAC/RCP1-1969 - General Principles of Food Hygiene.  This doc reads similar to the above "virus control" document.  It is intended to be used from primary production to the final consumer.  It describes areas such as Design and Layout, Water Supply, Monitoring Equipment, Cleaning, and Storage and Transport.  Effectively a facilities HACCP pre-requisite standards.  It finishes with HACCP basics and HACCP application.  This particular document (in my opinion) is a must read and a must learn.
5. Others - WOW! Docs for canning, dried fruit, eggs, frog legs, edible oils, corned beef, etc, etc, etc.  Lots of information to sink into and learn.

To see the Codex documents, click on the link below:

 www.codexalimentarius.org

Quantitave vs Qualitative Data

Back on March 29, 2013 I blogged about how to use Histograms as part of Statistical Process Control.  The Histogram I used dealt with numerical data (quantitative).  However, there is another type of data - Qualitative.  How do we plot this qualitative information?

Let's review the previous blog which included quantitative histograms.

In essence, a histogram is a collection of data points from a set of samples - let's say, for example, the weights of jelly filled donuts.  To get a reasonably accurate histogram will take about 50 data points.  These data points will outline the variability (measurement distribution) in the process - the variation of donut weights in our example.  For most processes, we will see a "normal" or bell shaped curve, as show below.  If you see multiple peaks, there is something affecting your variation that needs investigating.

 

Constructing the above histogram takes a few steps.  Step one is to gather your data.  Step two and three is to determine the data range and the number of classes (columns in the graph).  Step three is collecting the data into a frequency table (again the columns that will be used in the graph). Last step is to plot the columns into your histogram.  I do have to say that Excel does a great job on taking your data and quickly sorting it into a histogram ready form.  So here is our example below.

OK - the above is quantitative histograms, i.e. usage of measurement data.  Usage of a histogram is great for this type of information. Qualitative information is a bit different.  In qualitative date we talk in terms of items such as hair colour, gender, type of donut purchased.  The information does not lend itself to sorting into a chart such as a histogram.  In real life an example of this type of data is customer complaints received by customer service.  Yes, there is numerical information (# of jelly donuts with no jelly) but the type of information is qualitative.  This lends itself in being formed into Pareto, general bar graph, pie graphs.  An explanation of a Pareto is below.

A Pareto Chart is a very simple method of Data analysis that, at its heart is the 80 / 20 rule.  80% of the problems are from 20% of the causes.  Pareto charts can be used in charting events like customer complaints, where there are several types of issues.  The best way to proceed is to first collect the complaints and then organize them from most to least frequent.  Excel can do this task from a complaint list which is summarized in pivot table.  This pivot table can be charted and you can also add a line that tallies the frequency of each complaint.  When you reach 80% of the complaints, you focus on the issues that make-up that 80% amount.

 The above is a quick example of jelly donut issues at a retail store.  The left axis is the number of complaints and the right axis is the cumulative frequency of complaints.  Ordered in this way, it is easy to see "filling squirting out"  is the largest complaint but is this the only complaint to focus on?  The cumulative frequency reaches 80% at "donut crumbled".  So, to correct 80% of the problems we need to solve both the jelly squirting and donut crumbling issues.

ASPECTS OF FOOD FRAUD - PART 3 of 3

In the first two parts, of this series, I explained the different types of food fraud and why food fraud is such a large problem - not only from a safety point, but from a supply chain management and risk management perspective.  But how do we combat food fraud?  After all, food fraud has been around for as long as food has been bought and sold.

THE ANSWER????

Is the answer to prosecute the fraudster?  In part, yes.  However - even if we jail 4 of every 5, there would still be 1 fraudster doing what we don't want.  Plus, getting the evidence takes time and cooperation with government agencies (the police and customs for example).  As a company, do you wish to have the increased risk on your product for enough time to get the evidence needed to prosecute?  The risk is for the upper management to determine.  I believe the better way is prevention.




ITEMS NEEDED FOR PREVENTION

1. True "buy in" from Upper Management.  In other words a clear strategic direction, resources, and training.
2. Knowledge of national and international legislations and related Documents (the below is not an exhaustive list).  Learning a common language so you can talk about the issues, not only in the company but with subject matter experts at places like Michigan State University.
• ISO 31000 - Risk Management practices
• ISO 28000  - Security Management systems
• ISO 22000 - Food safety
• USP - US Pharmacopeia - methodologies to discovering adulterated products
• GS1 - Supply Chain Standards, best practices
• GFSI (codex) - Global Food Safety Initiative
• FD&C act chapter 4 section 401 subsection 342 - food adulteration(American Federal Food, Drug, and Cosmetics Act)
• TC 247 - Anti-Theft practices and becomes ISO 12931
• Canadian Food and Drug Act
• US Food Modernization Act
3. Potential designation of an employee who's main focus is looking at fraud
4. Finding out how food fraud can occur in your company - where are the weaknesses in your systems and procedures.
5. Detailing of the risk cost analysis stemming from the loss due to potential fraud.  This will need the help and advisement from account departments.  After all, QA and packaging personnel generally have little knowledge about business finance.  What is the tolerance level of risk for your company?
6. Being Watchful.  You will not be able to stop all fraud.  The fraudsters will continue to find new ways to get around you and your procedures.  Looking for trends (market monitoring, seizures, NCFPD database - EMA) and unusual occurrences is important.  Check out foodfraud.org - which is the USP

SUMMARY

Prevention of Food Fraud will take involvement and ideas from criminology, food science, Quality Assurance, Packaging, Procurement, sociology, economics, and others.  The point is to reduce the opportunity for the fraudster to penetrate your company and supply chain.  Increase the difficulty of fraud, increase the risk of getting caught, and decrease the economic advantages to the fraud.  Difficulty can be increased with better traceability, tamper proof packaging, authentication exercises, and security measures against theft.  These actions can be Overt (holograms on packaging), Covert (watermarks or black light marks), or Forensic (lab tests).

ASPECTS OF FOOD FRAUD - Part 2 of 3

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Thank - You.


How serious is FRAUD?  Let me pose a couple questions.

 - I mix 10% high fructose corn syrup into honey and sell it as 100% pure Honey.  I make more margin and it is not hurting anyone.
 - People can eat horse - so I mix horse meat into my beef - so what?
 - People can't tell the difference between Tilapia and Red Snapper.  So I make more money and sell the Tilapia as Snapper - it's still good quality fish!
 - I can get more by smuggling my green coffee from country X into country Y, re-bag and then sell it as country Y.
 - There is a lower import tariff on my cabbage if I say it comes from Mexico and not Canada.  It is still cabbage and a good product.  I am not hurting anyone.
 - The product is still good, it is OK to change the best used by date.

These are all statements to get several points across.  The first is that the fraudster is doing this to make/save money.  In the case of the honey, the corn syrup is not an allergen and is a safe, lower cost substitute.  The problem is, with this example and the others, there is no transparency to the supply chain.  If there is a problem with the corn syrup - good luck doing a recall because there will not be a record of this raw material adulteration.  Neither will you be able to do a complete hazard analysis because there is no information on the manufacturing conditions of the corn syrup.  Thus, you will not know how extensive the problem is in your product.

Secondly, Tilapia is half the price of Red Snapper.  From a consumer perspective - I am not getting the quality that I am expecting.  If I purchase a Lamborghini - I expect a Lamborghini engine, not a Volkswagen engine.  Not that there is anything wrong with a Volkswagen - it is just the fact that it is not what I purchased.  Money is tight for many people - why should we give money away so some one else can live better (without honestly working for it).

Third - The reason for import Tariffs is to discourage product dumping.  And again, when a country of origin is changed, any issue with the product cannot be traced back to the originator.  I seriously doubt that the company/people in country X have kept documentation of the change stating "produced in country Y". 

Fourth - By changing the ingredient, country origin, date coding, location of where the product can be sold, etc. You are increasing the food safety risk to the consumer.  You loose transparency on issues such as allergens, sanitation, pesticides, heavy metals, antibiotics, and quality - just to name a few.

Fraud is a crime of opportunity which may or may not cause a food safety issue.  The fraud could endanger customers, consumers, brand equity, employment, and trust in a company. 

In part three - how to combat food fraud.

ASPECTS OF FOOD FRAUD - Part 1 of 3

I have been investigating the issue of food fraud and find that it is much more complicated than I thought.  My impression was, food fraud dealt with people/companies selling unsafe product or substitution of raw materials.  I am right but only partially.  It is true that fraud can impact food safety and can be caused by people/companies selling unsafe product or by switching your raw ingredients.  However - this is a very limited view of food fraud.

What is Food Fraud?

1. Counterfeit products
• Same as counterfeit hand bags. 
• An unsuspecting customer can buy this when there is a problem, call you
• Against Intellectual Property laws (misappropriation of logo, patent, trademark, etc.)
2. Adulterated ingredients
• Supplier sells you an item that is not as contracted - Honey mixed with corn syrup when you purchased 100% Honey
• Your Company running out of an ingredient and substituting an alternate
3. Smuggling of product to alternate markets
• Country x labelling the product as country z to avoid high Tariffs or to increase the price
• Big in the coffee industry where coffee can cross a border and now have a price that is 5 cents or more higher.  This does not seam like much but each container of 40,000 lbs will net $2,000 US dollars extra if at the 5 cent increase level.
• Also big with Honey - a country will avoid custom tariffs by cross docking and changing paperwork to look like it came from a different country (one with lower custom tariffs)
4. Manufacturing of near identical copies
• Similar to number 1. but with a slightly altered colour, wording, etc.
5. Production overrun
• Your co-packer or one of your facilities makes 100 units as per your order request.  The facility makes 200 - 100 units for you and 100 units for themselves.
6. Tampered product
• Changed Best by dating or lot code information.
• repackaging of a damaged product known to be comprised
7. Mislabelled product
• Wrong Allergen information
• Fraudulent nutritional information
• Wrong net weight or unit count
8. Known contamination
• Food has been tested and is unfit for consumption or is a lower grade than advertised.  It is still sold or remixed into good product to dilute the contaminant
9. Theft of product
• Your product is stolen from the truck, warehouse, store, or production facility and it finds a way into consumers hands.
10. Diversion of product
• Product is sold to a market where it was not to have been sold.

Very long list.  The common string in all the above is, they are crimes of opportunity.  Also the "fraudster" is always looking to get around a country's and your company's laws, rules, practices, and procedures.

Next - I will look why this Fraud is dangerous to consumers.

Internal Audits - Part 1 of 2

Introduction

I have been blogging about SPC (statistical Process Control), which is a great way to accumulate data on your process.  Another method of data collection is auditing.  Auditing will tell you much more than just numerical information and will bring a more visible presence of the programs to the employees.  As part of a GFSI (Global Food Safety Initiative) program - you will find the relevant sections under 2.5.7 in SQF edition 7 and section 3.4 in BRC edition 6.

What needs to be audited

In short - all activities that are being done on the production floor need to be audited.  Specifically mentioned in the BRC and SQF codes are all prerequisite programs, HAACP program, programs in place to maintain/achieve standards (example - maintenance program and warehousing program), food quality program (SQF level 3), and all government regulatory requirements.  In the two codes, only BRC states that hygiene, equipment, and building audits must be at least once per month.  All other audits are at least annually or based on risk analysis.  Please note, the higher the risk to product safety, the higher the frequency of audits. Personally, I typically see hygiene audits once per shift.  Of course the frequency of audits will be higher when a new or improved program is begun and the frequency should decrease as people understand what is required from the program (less non-conformances).

Non-Conformances

An interesting notion on non-conformances is, if the auditor can correct the non-conformance during the audit, then it is a responsibility of the auditor to make the correction.  All corrections and non-conformances need to be written and actioned.  Actioning a non-conformance means that a corrective action is created with a timeline for completion.  Without the completion timeline, I find the correction gets placed in the "I will do this tomorrow" box and tomorrow is always tomorrow never today.  If the non-conformance has a potential risk to food safety it may need to be communicated to upper management.  This communication is to ensure that other company managers know that the non-conformance needs to be corrected and if funds or external help is required - then the appropriate help and funds are made available.

Summary

All audits will need to be placed on an audit schedule with the who, what, where, and when items defined.  Who, keeps this schedule?  The lead auditor keeps the schedule - usually the QA Manager.  This lead auditor will also need to keep upper management informed about non-conformances and corrective actions.  A great way to summarize the information is by construction of a Pareto diagram (see statistics blog part 2).  Also to chart the information as a KPI (Key Process Indicator) where the number of non-conformances or overall audit scores are mapped monthly.  An overall score would need the development of a numerical system on each audit form to make it possible to create a KPI around the audit.

Part 2 will look at what elements are being looked at and what makes a good auditor.  I will also look at the various audit areas and what should be "in" the audit.

How You can use Statistics in the Food Industry - Part 5

In this last part of the series I wanted to go through 2 items one being 6 Sigma and the other putting together an SPC program with the methods that I have blogged about.

6 Sigma

6 Sigma is a program that is taught for industry and the name comes from the following concept.  At +/- 6 sigma (6 standard deviations) from the mean (average) of a process you will have 3.4 off specification units per million units produced.  Yes, I am use to seeing +/- 3 Sigma as the standard so 6 Sigma seams rather extreme.  However - considering the thousands of parts in a car, having each part at +/- 3 Sigma there would be a lot of defective cars on the road (the off spec parts are cumulative).  I will stick my neck out and comment that in some cases, 6 sigma IS extreme.  Consider the roasting of whole bean coffee.  There is one raw material and only 3 steps.  Roasting, weighing, and bagging.  In such a simple system - +/- 3 sigma is probably OK

In either case - it is the upper and lower specification that determines how much variability can be tolerated in your process.

SPC Program

The following is an example of putting together a SPC program.  This type of program cannot be created overnight - it will take time, training, patience, and support from MANAGEMENT.  Here are the steps of my example (NOTE - this will need to be repeated at each process step that you are doing testing):

1. Brainstorming - figure out (as a group) what you want to accomplish and at which points of the process.  Fishbone diagram is a good technique at this point.
2. Initial run charts - Creation of a run chart and training in the usage of the chart.  This will get you data to analyse.
3. Plot your Histogram and run your Cp and Cpk study to see if you are in control of the process step and have a normal distribution curve.  If you are in control and have a normal distribution then proceed to step 5, if not go to step 4.
4. Not in Control? Run a gauge R&R to find where the variation is coming from.  With the R&R test results you may need to do a root cause analysis (Fishbone, 5 Whys) and correct for the variation.  This correction will likely require retraining of the staff.  Redo step 3.
5. Great, you are in Control! - Redo your run charts if necessary, taking advantage of the lessons that you have learnt to this point.
6. Monitor - Keep the run charts and histograms going.  This is also your verification step.
7. Out of spec product - you can get samples of out of spec product and do a root cause analysis on them.  For me, this gets linked with customer complaints and is a great place to do a Paredo chart.  Based on the root cause analysis you will need to put a "plan of action" together to correct the issue.
8. The second to last step is the creation of a checklist.  The checklist is used at a frequency that is determined by risk and you.  This is also called the Validation step.  The checklist can include such items as;
• Training record check
• Log check
• Are the calibrations being done
• Preventative maintenance cycles completed
• Observation of the people (are they following protocol)
• Check on the written procedures (are they current, legible, visible)
• View the process
• Review the Cp, Cpk, Histograms, and any corrective actions
9. The last step - return to step 2.

Again - this will need to be done at each testing point of your process - which is why I said that doing an SPC program will take a lot of time and patience.

How You can Use Statistics in the Food Industry - Part 4

Gauge R&R

Gauge R&R (Reliability and Reproducibility) is a method to look at personnel, protocols and equipment when studying your quality control checks. 

1. Are your operators doing the checks the same way?
2. Are our protocols / procedures being followed?
3. Is the equipment (gauges) acceptable for the task that is being performed?

The statistics on this are fairly heavy and yes, I use Excel to do the calculations.  There are some free programs that will do the heavy lifting for you.  Here is what you need to do for a gauge R&R study:

1. Make sure that your measurement device is functioning correctly, calibrated, and the same device is used for all tests.
2. Three operators is optimal - you can use two but the results will not be as accurate.
3. Ten samples that each operator will test three times (mix the samples up so the operators will not know which sample is which).  These samples should be representative of your process.
4. Run the test and plug in the results into your program.
5. You will need to capture the average and ranges for each sample on each test as well as the average for each operator on each of the three tests.

What will come out of the program is the variability of the samples vs. the operators in both numerical and graphic terms.  What you want to see is a total variability below 30%.  Let us take our Jelly Donut example where we tested ten donut weights - the information from an Anova test could look like:

% Gauge R&R = 36.8%
-Reproducibility=-0.4%
-Repeatability=13.9%
-Donut to Donut=86.5%
So, the total number of 36.8% is much higher than the needed 30% - OUCH! Reproducibility is the measure of the variation from the operators - Great! if we had a higher variation for the operators we could look at how the operators are performing the weight checks. The repeatability is variation from the equipment - OOPS - at 13.9% this needs to be corrected.  Either the equipment is faulty or maybe not sensitive / accurate enough.  Looks like we need a "more accurate scale".  The Donut to Donut variation is 86.5% which is good.  You want most of the variability to be found in the product.  As the variation in the equipment and operators decreases, more variation will be accredited to the product.

What about graphs?  Everyone likes to see a visual that summarizes and makes the results very clear.  From the above example we could look at the variation between the operators based on the averages of the samples.

From this Operator 1 and 3 are close to each other but operator three has more variation in the average weights of their samples.  Operator two is quite different from the others.  Visualizing this definitely pin points the need of retraining operator 2.

 

 

The last item to discuss is the type of samples you need to perform this analysis.  The above works really well on non-destructive testing.  If the test is destructive, you will need to do one of two things;

1. Find a method to simulate the destructive test non-destructively.
2. Find enough "identical" samples to run the test

How You can Use Statistics in the Food Industry - Part 3

Recap:
So far we have looked at Paredo, Histograms, Run charts, and Fishbone diagrams.  What next?  Process Capability, Gauge R&R, 6Sigma, and SPC.  Is there more than this - yes, but I think, once the above list is complete - further info would need to be part of a statistics course or a "6 Sigma (green or black belt) program".

Process Capability:

To begin a project of statistical process control, you need to start with a couple of tasks.  The first task is to construct a histogram of your test results to see if you have a normal curve and if your process falls within your upper and lower specification limits - is your process in control (this can be done visually - see part 1 of this series, or by doing a chi squared test)?  The second task is to do a process capability which can only be done if your process is in control. 

In process capability, there are two steps - The Cp and the Cpk.  Cp is a simple index that relates your processes spread to the upper and lower specification limits. 

1. If Cp is >1 you are in good control (the specification limits are wider than your variation)
2. If Cp=1 your specification limits are the same as your variation and 0.3% defect are being made. 
3. If Cp is > 1 your product variation is greater than your spec limits and you are making a lot of scrap. 

The calculation for this number is the upper spec limit minus the lower spec  limit.  The result is then divided by 6 multiplied by the "estimated process standard deviation" 

USL-LSL

6*STDDEV


The deviation is calculated by Range (or average of the ranges for all subgroups) divided by a factor called d2.  Where d2 comes from is a chart of factors for computing Central lines for X and R charts.  I have found a link (below) for this chart of factors.

http://www.dfx.nl/userfiles/file/pdf/Control%20Chart%20Constants%20and%20Formulas.pdf
 

The second task is the Cpk which not only takes into account the variation (spread) of the process but also asks "is the process centered?".  In other words is the mean of the histogram dead centre between the specification limits or is it closer to the upper or lower limit. 

1. If you are below 1, you are not centered and your processes variation is falling outside of the upper or lower specification limit. Thus producing out of spec product, as shown below:
   
2. At 1 to 1.33 you are OK but with no margin for error or drift (running the process too tight).  The process variation is right against either the upper or lower spec limit.
   
3. Above 1.33 - the higher the number the more room you have between your variation and the nearest specification limit.  You may wish to tighten-up your control limits in this case.

Once you have your data points, calculate the average (mean) and the standard deviation.  Subtract the mean from the upper spec limit and divide by 3 X standard deviation.  Do this calculation for the lower spec limit by subtracting the lower spec limit from the mean and then dividing by 3 X standard deviation.  The smaller of the two numbers will be your Cpk (also the spec limit your process is closest to). Equations;

USL-AVE

3*STDDEV

 And

AVE-LSL

3*STDDEV

 Free software at qualityadvisor.com is available as a quick and easy method of getting at this metric.  You will need to know how to select the subgroup size.  1 subgroup is one set of data from one lot and one production run.  Two subgroups would be data from two operators, two lots, etc.

For more information on the calculations, please take a look at isixsigma.com

 

Internal Audits - Part 2 of 2

In part one; I talked about what needs to be audited and about a few of the basics around auditing.  In part two, I will talk about some of the specific areas to look at during auditing and what makes a good auditor.

What makes a good Auditor?

In short, an auditor needs to be observant and have integrity.  Being observant means to be equipped with the proper tools such as a flashlight, mirror, knee pads, or any other tool that may be needed.  Personally; I like to think like an auditor.  If I think an auditor would use a ladder to look at refrigeration coils - I would use a ladder to inspect these coils myself.  A good rule is to think like an auditor before an auditor arrives.  Persistence and ability to deal with conflict are other traits that will be needed.  Let's face it, internal auditors will need to observe and measure what their friends and coworkers are doing - this will definitely setup conflicts.  No-one likes being watched and graded!

Lastly the auditor needs to be familiar with the general operation of the facility and be knowledgeable on the principles involved with the system / program / or element that is being audited.  Yes, auditors needed to be trained and the training needs to be refreshed every year as per SQF ????? and BRC section????.  SQF section 2.5.7.2 states that it would be ideal to have the auditors performing the checks on an area that is not part of their normal responsibilities or job duties.

Audit List Considerations

In general, HACCP, pre-requisite programs, and other regulations (organic, Kosher, etc.) need to be considered.

· CCPs (Critical Control Points) and QCPs (Quality Control Points) consider;

• Are the process flow Diagrams correct?
• Monitoring methods and frequencies adhered to
• Records being kept and legible (no pencil or white out) - signed, dated, completed
• Calibrations and records being completed - on schedule
• Review any recent corrective actions and are they completed

· Personnel

• Hygiene and cleanliness of the staff
• Rules on clothing are being adhered to
• Protective clothing and hair restraints being worn
• Signage is visible and appropriate
• Common areas are clean - including the inside of lunch fridges and microwaves
• Personal items are not worn - jewelry, cell phones, etc.

             · Visitors

• Signed in and wearing badges
• Have read and signed the policies and procedures that are required

· Chemicals and Storage

• Storage secured and lockable - is the lock being used
• Staff is trained
• Signage and handling instructions available
• W.H.I.M.I.S. and M.S.D.S up-to-date
• Transfer vessel cleanliness and condition
• Usage and inventory logs up-to-date
• Chemicals properly / legibly labelled
• Food grade chemicals and lubricants separated from non-food grade
• Hand/foot dips and hand sanitizers being used, monitored and maintained

· Toilets and Hand washing areas

• Clean and sanitary
• Warm water and soap available
• Paper towels and trash can available

· Cleaning and Sanitation Program

• Master sanitation schedule maintained, current, and followed
• Procedures available and being followed
• Cleaning material and equipment clean and properly stored
• Correct clothing being worn
• All materials are appropriate for the job
• Verifications being completed and recorded

· Pest Control

• Technician has a current liscence
• Maps are current
• Traps are clean, numbered, functional, and in their proper places.
• Service records and corrective actions are completed
• M.S.D.S sheets and technician licence up-to-date
• Bird control documented

· Other Areas for auditing

• Production area
• Storage area
• Shipping and receiving
• Maintenance workshop
• Exterior surroundings
• Record security
• Allergen program
• Foreign material
• Food Defence and Security

I am sure that this is not an exhaustive list and I could continue for a lot longer.  However, I think you get what is needed.  As a last note - make sure that all audits are recorded in writing and all corrective actions are completed on time.